We've gotten word that the FDA has approved the exciting Dexcom SHARE system, the first mobile device approval of its kind that allows data from a continuous glucose monitor to be beamed via Bluetooth wireless technology to as many as five smartphones anywhere!
The San Diego-based CGM company Dexcom announced on Monday that it had received FDA approval, 15 months after submitting the device for review in July 2013.
Yes, it's SHARE with all caps... because we're not just talking about sharing data by pushing it via email to a doctor somewhere, but rather transmitting it in real time to up to five phones that can be located anywhere in the world.
This approval and the discussions that led up to it are pretty exciting because they appear to be setting the stage for FDA's increasingly nimble approach to reviewing new diabetes mobile tech, and may influence how regulators deal with other data-sharing tools -- such as those Tidepool and Nightscout/CGM in the Cloud developers are working on and discussing with the FDA now.
Some Nightscout proponents are already grumbling that Dexcom SHARE seems to be outdated on arrival, given that thousands of people are already hacking this solution that lets them view their CGM data on any device. But remember, Dexcom SHARE has two major advantages: 1) it is a complete product already, that requires no complicated multi-device setup like Nightscout, and 2) it is an FDA approved product that's supported by the very company that makes the CGM itself, so users get tech support and safety guarantees, etc.
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Detail about Dexcom SHARE first began circulating publicly more than a year ago following an investor relations call, and we were able to publish photos and some details on the product while the D-Community waited for word from the FDA. Dexcom's clearly been expecting the decision for awhile, because the Dexcom SHARE page went live online as a placeholder in March, offering a welcome area and a variety of links that could be quickly activated once the SHARE was cleared.
You can check out this promotional video explaining the new SHARE. We also found some FCC filings online (required for wireless communication devices), that offer even more detail about how the product will work -- everything from cover letters about the new device to pictures of the inside and outside, and even the 88-page user manual.
Based on all of the info available, here's a rundown of what we know so far:
- SHARE is a docking station or "cradle" that you slide your G4 receiver into, allowing it to both charge and send data.
- Rather than just display the data on an alarm-clock-like screen like the Medtronic MySentry system does, SHARE sends the data to a web-based cloud, which will eventually be Dexcom SweetSpot (Dexcom acquired SweetSpot data logging tech in 2012).
- You can then use both the Dexcom SHARE app and its companion app, called "Dexcom Follow" to access that data and get High or Low alerts on as many as five smartphones in other rooms, homes, cities, or... well, anywhere.
- It works using radio chips built into the cradle that receive the G4 sensor data and forward that to a "host" cell phone nearby using Low Energy Bluetooth. Initially, this will be an Apple-only device -- meaning it only works with iPhones and iPod or iPod Touch devices and nothing on Android, for now.
And btw, Dexcom has just released a new slimmer G4 transmitter. Last week, we began hearing about this revised transmitter that's thinner than what the current model and more along the lines of what the former 7+ transmitter looked like. Dexcom tells us this was a "soft launch" and there isn't anything else different, as it has the same accuracy and range. Each new transmitter box has a round sticker that proclaims, "New! Slimmer profile!"
Regarding the new SHARE: it's based on a stationary docking device that you need to plug in, for now. So opinions may vary on whether this offering is "portable" enough for every situation. Those who aren't excited about the plug-in could probably buy a portable battery to keep the SHARE juiced. But the revolutionary part is allowing reliable real-time data-sharing from any distance, and in showing it off, the company's talked up the usefulness for D-parents or adults PWDs while they travel, or while D-kids are at sleepovers, etc.
Indeed, with the G4 getting pediatric approval for kids as young as 2 just recently in early February, it seems that Dexcom's well-positioned to market this as a great tool for children with diabetes and their parents, while of course offering it as a resource to adult-CGMers as well.
Cost & Coverage
Word is that Dexcom reps were pressed to complete their training early in the year, allowing the company to "get all its ducks in a row" to start selling as soon as possible following FDA approval. Customer service said Monday morning that you can buy the Dexcom SHARE immediately via the Dexcom website, where it's listed at a price point of $299 (one-tenth the $3,000 cost of the Medtronic mySentry, that doesn't share data).
Dexcom says they don't expect SHARE to be covered by insurance since it's an "add on" type device that patients will generally have to purchase out-of-pocket. Of course, that doesn't prevent anyone from trying to submit it for insurance coverage; the more folks who apply, the more likely that insurers will recognize the demand for a tool of this type.
Dexcom also says they thought about launching this as a subscription service in which patients would have had to pay for the data, but opted instead to just release all the data to customers for free (good choice!)
Looking through the user manual, we found reference to a cool-looking thing called the GlucoMonster -- which admittedly sounds very similar to the little diabetes monster featured in the popular MySugr logging app. But these Dexcom SHARE materials appear to pre-date the launch of MySugr.
Here's how Dexcom's monster was described, at least in these early SHARE materials:
The caveat to all of these new mHealth and data sharing apps is of course FDA's cautious approach to allowing medical "decision-support" from a smartphone. Although they just recently offered guidance on how they plan to tackle mobile medical apps, the rules aren't exactly clear.
Of course, some in the D-Community have taken matters into their own hands, embracing the battle cry of #WeAreNotWaiting and developing their own hacked solutions including CGM watches, Nightscout/CGM In The Cloud and the Do-It-Yourself Pancreas System.
Whether Dexcom SHARE goes as far as these other "do it yourself" systems isn't really the point; the regulatory approval is. Hopefully this move will further encourage everyone from regulators, device-makers and tech-savvy consumers to work together to bring more of these types of innovations to reality.
On that note, Dexcom is talking with Apple about integrating its product with the still-in-development Apple HealthKit (!). And Medtronic is also prepping its next-gen "Guardian Mobile" technology that would be a smartphone-enabled CGM that uses Bluetooth LE tech to communicate.
Waiting on G5
As exciting as it is, Dexcom SHARE is pretty much a placeholder device that allows the G4 sensor data to be shared with mobile devices before the launch of the eventual G5 sensor, which will eliminate the need for a receiver altogether and allow for direct-to-smartphone communication. Last we heard, Dexcom is still planning to have the G5 ready for FDA submission sometime in early 2015.
Dexcom's Kevin Sayer (who takes over as CEO on Jan. 1, 2015) also offered this tidbit: "G5 is going to be focused largely on connectivity, mobility and convenience. And it will come out more than likely as a series of launches rather than one big launch, with the end goal of G5 being a simplified application system, combined with connectivity to a phone in addition to being connected to your receiver and cloud-based data. We'll go there in a series of steps. That system will use the G4 sensors current configuration, but with new algorithms that we've developed over the course of the past few years that will improve accuracy and reliability."
So it appears the new Dexcom SHARE truly is a stepping stone toward the company's more sophisticated mhealth vision -- which in my head, is like the yellow brick road that leads to a big beautiful city full of... mind-blowing stuff.
With this Dexcom SHARE approval, it's pretty clear: the future of diabetes innovation is now!